Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression
NCT06813313, Not applicable, Not yet recruiting, Dominique JANUEL
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Theta Burst Stimulation With an 8-Coil Versus H1-Coil for Resistant Depression | ClinicalTrials.gov |
| NCT number | NCT06813313 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 108 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Dominique JANUEL | ClinicalTrials.gov |
| Conditions | Treatment of Resistant Depression, H1-Coil, Theta Burst Stimulation | ClinicalTrials.gov |
| Interventions | repetitive transcranial magnetic stimulation | ClinicalTrials.gov |
| First posted | 2025-02-06 | ClinicalTrials.gov |
| Last updated | 2025-02-06 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The response rate according to the MADRS scale | Before the treatment and after the treatment at 5 day. | The response rate is defined as an improvement of more than 50% compared to baseline on the MADRS clinical scale (Montgomery-Asberg Depression Rating Scale). The MADRS consists of 10 items, each scored from 0 to 6 : depressive mood, appetite, sleep, psychomotor retardation, anxiety, suicidal thoughts, cognitive impairment, pessimism, loss of control and demoralization. The total score is the sum of the scores for all 10 items. The overall score can range from 0 to 60. 0 to 6: No depression 7 to 19: Mild depression 20 to 34: Moderate depression 35 to 60: Severe depression | ClinicalTrials.gov |
| Secondary | Clinical improvement of treatment-resistant depression | Before the treatment and after the treatment at 5 days. | We use: \- MADRS (Montgomery-Åsberg Depression Rating Scale) : Remission: A MADRS score of less than 10. | ClinicalTrials.gov |
| Secondary | Clinical improvement of treatment-resistant depression | Before the treatment and after the treatment at 5 days. | We use: \- HDRS-17 (Hamilton Depression Rating Scale - 17 items): The scale contains 17 items, each scored on a scale from 0 to 4, 0 to 2, or 0 to 3, depending on the item. The total score is obtained by adding the scores of all 17 items. The total score can range from 0 to 52. Response: A reduction of 50% or more in the total HDRS-17 score compared to baseline is generally considered a response to treatment. Remission: A score of 7 or less is typically considered remission from depression. | ClinicalTrials.gov |
| Secondary | Clinical improvement of treatment-resistant depression | Before the treatment and after the treatment at 5 days. | We use: \- QIDS-SR : The patient answers the 16 items, each assessing various depressive symptoms, and the score ranges from 0 to 27, based on their experiences over the past week. A 50% reduction in the total score from baseline is considered a response. | ClinicalTrials.gov |
| Secondary | Clinical improvement of treatment-resistant depression | Before the treatment and after the treatment at 5 days. | We use: \- EQ5D : The EQ-5D is a brief tool for assessing health-related quality of life. It measures 5 key dimensions of health. | ClinicalTrials.gov |
| Secondary | Tolerance to treatment | Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month. | Rate of adverse effects and rate of premature withdrawal from the study. | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Trail Making Test A and B (version from the Group for the Evaluation of Executive Functions, GREFEX, Army individual test 1944, based on Godefroy, 2012) | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Free Recall / Cued Recall at 16 items (RL/RI-16), version A or B | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Stroop Test (Golden, 1978) | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Wisconsin Card Sorting Test (WCST), GREFEX version | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | N-back Task (version from the Attention Assessment Tests, TAP) | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Go/No-Go Inhibition Task (TAP version) | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Digit Span and "Coding" subtest from the Wechsler Adult Intelligence Scale (WAIS-IV) | ClinicalTrials.gov |
| Secondary | Improvement of cognitive functions. | Before the treatment and after the treatment at 5 day. | Verbal Fluency Test (GREFEX version) | ClinicalTrials.gov |
| Secondary | Improvement of neurophysiological functions | Before the treatment and after the treatment at 5 day. | Variation in brain functional connectivity between baseline and the end of the rTMS treatment. | ClinicalTrials.gov |
| Secondary | Improvement of neurophysiological functions | Before the treatment and after the treatment at 5 day. | Neurobiological/neurophysiological variables: change in heart rate variability. | ClinicalTrials.gov |
| Secondary | Improvement of neurophysiological functions | Before the treatment and after the treatment at 5 day. | Change in serum BDNF levels. | ClinicalTrials.gov |
| Secondary | Improvement of neurophysiological functions | Before the treatment and after the treatment at 5 day. | Change in motor cortex neuroexcitability. | ClinicalTrials.gov |
| Secondary | Pain detection and pain tolerance using an experimental pain task | Before the treatment and after the treatment at 5 day. | Cold pain using the cold pressor task and mechanical pain using the algomete | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)